This guide to bone and tissue transplantation is provided by the American Academy
of Orthopaedic Surgeons (AAOS) and the American Association of Tissue Banks (AATB).

Your physician has recommended that you have a surgical procedure in which a bone
or other musculoskeletal tissue will be used.

The Importance of the Musculoskeletal System

The musculoskeletal system is a network of muscles, bones, joints, tendons, and ligaments
that provide us with the ability to perform the tasks of daily living.

Musculoskeletal disorders and diseases significantly impact the quality of life. These
disorders are the most frequently reported impairments in the United States. More
than 100 million Americans have musculoskeletal conditions with limitations of function
that are chronic and permanent.

The cost to our society for these conditions exceeds $800 billion every year. The
human cost, however, goes beyond dollars. Limitation of activity, nagging or severe
pain, unsightly deformity, or the inability to function normally each have enormous
impact on the quality of life.

Orthopaedics is a medical specialty that deals with the musculoskeletal system and
uses medical, physical, and surgical methods to restore function lost as a result
of injury or disease. An orthopaedist, also called an orthopaedic surgeon, is a highly
skilled physician trained in a variety of medical and surgical techniques that will
be used during your surgery. The lengthy educational process that is required to become
an orthopaedic surgeon helps assure a high level of skill and competence.

As you may be aware, many people choose to donate their organs and tissues. These
otherwise healthy people often become donors as the result of an unexpected death.
Most allograft musculoskeletal tissue used comes from such donors. Occasionally though,
allograft bone may come from a living patient.

A tissue bank is an organization that provides donor screening, recovery, processing,
storage, and/or distribution of allograft tissue. Specialists trained in transplantation
recover and process donated musculoskeletal tissues. These professionals are well
trained and most have passed a rigorous examination that certifies them on the basis
of their knowledge in all areas of tissue banking including decontamination techniques,
quality assurance, quality control, product testing, labeling, and record keeping.

The American Association of Tissue Banks is the national standard-setting organization
that provides this certification. Presently, not all tissue banks are AATB accredited.
However, tissue banks may choose to undergo this voluntary accreditation.

Before donation, all potential donors must undergo strict screening scrutiny that
includes physical examination, comprehensive medical history, and social risk review.
A detailed medical history that includes social risk background and medical issues
is obtained. The information collected on potential donors is compared against criteria
established by the United States Public Health Service to identify and exclude individuals
with high-risk behaviors. Furthermore, all tissue is held in quarantine until microbiological
and blood tests are completed. These tests are required by the AATB and the U.S. Food
&
Drug Administration (FDA), and include analysis of infectious diseases including HIV,
hepatitis B and C, and syphilis.

All of the information is evaluated by a team of medical specialists in the fields
of infectious disease and tissue banking. No allograft can be released until the tissue
bank's medical director determines the tissue to be safe after review of the screening
and testing information.

Preparing the tissue for transplant begins with the removal of debris and organic
matter. The allograft is then soaked in various solutions to prevent the transmission
of bacteria and viruses. Processing and packaging are performed using sterile techniques
in clean room conditions to maintain biological integrity. On occasion, low dose radiation
is used to aid in sterilization. Final processed tissues are tested for microbiological
contamination in accordance with United States Pharmacopeia (USP) guidelines to ensure
compliance with regulatory requirements. Although there is some theoretical risk for
disease transmission, the use of allografts that have undergone rigorous donor screening,
serological testing, and formal processing has significantly reduced this risk.

The FDA has regulated this field very closely since 1993 to ensure the safety of allograft
transplant. Over the past decade, more than five million musculoskeletal allografts
have been distributed to surgeons for transplant into patients with a remarkable record
of safety.

It is illegal to buy or sell human organs or tissues. Costs for recovering organs
and tissues for donation are never passed on to the donor or the donor family.

Many protocols are followed in tissue banks to ensure safety. Tissue banks insist
on professional expertise in maintaining uniform and standardized donor screening,
testing, quality control, and state-of-the-art applications of processing procedures.
They also explore advancements in the areas of tissue sterilization and incorporation
of bone grafts into the body. Tissue banks must also keep abreast of the development
of new products, processing procedures, and FDA regulations regarding good manufacturing
processes. All these efforts represent the costs of providing the utmost safety in
allograft tissue. These expenses are then passed on to the hospital, surgeon, or recipient.
Costs are kept at a minimum, but must cover personnel and services in the areas of
acquiring, processing, and storage of the allograft.

Some tissue that does not meet the criteria for transplantation for human use is directed
to research projects in order to advance the science in musculoskeletal transplantation.
Other selected tissue may go into programs of tissue engineering.

The American Association of Tissue Banks, organized in 1976, has been an accrediting
agency since 1986. The FDA began providing significant oversight in 1993 with regard
to tissue banks when it began formal regulation of tissue banking. The purpose of
the AATB is to standardize the operations of participating tissue banks throughout
the United States and to achieve nationally recognized uniform levels of safety and
quality in allograft transplants. Accreditation status by AATB further ensures that
a bank has met national standards for donor screening, procurement, processing, and
storage of human tissue. Each bank voluntarily agrees to be inspected every three
years to insure compliance in providing the safest tissues possible for transplantation.
Only laboratories listed under Clinical Laboratories Improvement Act (CLIA) and only
FDA-licensed tests can be used. AATB continues to work closely with the FDA to ensure
an exemplary record of safety to the American public.

The American Academy of Orthopaedic Surgeons represents more than 34,000 members.
The Academy is the world's largest and most influential medical organization of orthopaedic
surgeons dedicated to providing the highest quality musculoskeletal care. The AAOS
believes that musculoskeletal allografts provide beneficial treatment for appropriate
patients.

AAOS does not endorse any treatments, procedures, products, or physicians referenced
herein. This information is provided as an educational service and is not intended
to serve as medical advice. Anyone seeking specific orthopaedic advice or assistance
should consult his or her orthopaedic surgeon, or locate one in your area through
the AAOS "Find an Orthopaedist" program on this website.